Principal Quality Engineer Medical Devices

Job Summary

We are seeking a dedicated and experienced Principal Quality Engineer to drive and maintain the highest standards of product quality and regulatory compliance within our medical device manufacturing operations. This role is critical for ensuring adherence to FDA regulations and ISO standards encompassing responsibilities from design control and supplier management to advanced statistical analysis and quality auditing. The ideal candidate will leverage their expertise to proactively identify and mitigate quality risks contribute to continuous improvement and uphold our commitment to excellence in a highly regulated environment.

Responsibilities

• Perform and support internal quality audits to ensure compliance with regulatory requirements and company standards.
• Manage and oversee quality aspects of contract manufacturers and other suppliers
• Analyze customer complaints and conduct appropriate investigation to increase customer satisfaction
• Utilize statistical knowledge including sampling plans control charts Design of Experiments (DOE) and ANOVA for process monitoring improvement and problem-solving.
• Conduct data mining trend analysis and present findings to identify areas for quality improvement and risk mitigation.
• Ensure adherence to GMP (21 CFR 820) and ISO 13485 quality system requirements throughout all quality engineering activities.
• Develop and maintain excellent technical documentation including support for CE marking activities.
• Collaborate effectively with cross-functional teams demonstrating excellent interpersonal skills self-motivation and a proactive approach to quality assurance.

Qualifications

• Bachelors degree in engineering preferred
• Preferred certifications: ASQ CQE CMQ/OE CQA/CBA.
• 4 years of experience preferred
• Prior medical device manufacturing experience is required
• GMP (21CFR820) and ISO 13485 knowledge and experience
• Ability to perform internal quality audits
• Prior experience in supplier management/contract manufacturing preferred
• Knowledge of Design control in a FDA regulated industry
• Statistical knowledge including sampling plans control charts DOE ANOVA etc.
• Experience in data mining trend analysis and presentation preferred
• Excellent technical writing skills with CE marking knowledge preferred.
• Excellent interpersonal skills self-starter and self-motivated

Anticipated salary range:$70400 - $100500

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close:3/10/26 *if interested in opportunity please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidates geographical location relevant education experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work people with disabilities without a college degree and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin ancestry age physical or mental disability sex sexual orientation gender identity/expression pregnancy veteran status marital status creed status with regard to public assistance genetic status or any other status protected by federal state or local law.

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